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Trial record 11 of 17 for:    "Connective Tissue Disease" | "Ethanol"

Individualized vs. Household MRSA Decolonization (HOME2DS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01814371
Recruitment Status : Completed
First Posted : March 19, 2013
Results First Posted : October 26, 2018
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Stephanie A. Fritz, Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Staphylococcal Skin Infection
Abscess
Furunculosis
Staphylococcus Aureus
MRSA Infection
Interventions Drug: 2% mupirocin ointment
Other: Bleach Bath (dilute)
Behavioral: Hygiene Protocol
Enrollment 474
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Individualized Approach Household Approach
Hide Arm/Group Description

The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.

All members of the household will perform the decolonization regimen.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.
Period Title: Overall Study
Started 248 226
Completed 218 199
Not Completed 30 27
Reason Not Completed
Lost to Follow-up             30             27
Arm/Group Title Individualized Approach Household Approach Total
Hide Arm/Group Description

The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.

All members of the household will perform the decolonization regimen.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.
Total of all reporting groups
Overall Number of Baseline Participants 248 226 474
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 248 participants 226 participants 474 participants
<=18 years
145
  58.5%
128
  56.6%
273
  57.6%
Between 18 and 65 years
101
  40.7%
97
  42.9%
198
  41.8%
>=65 years
2
   0.8%
1
   0.4%
3
   0.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 248 participants 226 participants 474 participants
18.65  (16.65) 18.69  (15.94) 18.67  (16.30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 248 participants 226 participants 474 participants
Female
134
  54.0%
124
  54.9%
258
  54.4%
Male
114
  46.0%
102
  45.1%
216
  45.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 248 participants 226 participants 474 participants
Hispanic or Latino
16
   6.5%
13
   5.8%
29
   6.1%
Not Hispanic or Latino
232
  93.5%
213
  94.2%
445
  93.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 248 participants 226 participants 474 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
67
  27.0%
59
  26.1%
126
  26.6%
White
169
  68.1%
162
  71.7%
331
  69.8%
More than one race
12
   4.8%
5
   2.2%
17
   3.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 248 participants 226 participants 474 participants
248 226 474
Height (inches)  
Mean (Standard Deviation)
Unit of measure:  Inches
Number Analyzed 248 participants 226 participants 474 participants
54.95  (14.53) 55.24  (15.80) 55.09  (14.65)
Weight (pounds)  
Mean (Standard Deviation)
Unit of measure:  Pounds
Number Analyzed 248 participants 226 participants 474 participants
114.09  (77.19) 121.74  (88.25) 117.85  (82.81)
1.Primary Outcome
Title Number of Participants With Incidence of SSTI at 3 Months After Decolonization
Hide Description Cumulative Number of Participants with SSTI at any time during the 3 Months following Decolonization protocol
Time Frame 3 months after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
447 of 474 participants were analyzed. The remaining 27 participants were lost to follow up for this time frame.
Arm/Group Title Individualized Approach Household Approach
Hide Arm/Group Description:

The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.

All members of the household will perform the decolonization regimen.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.
Overall Number of Participants Analyzed 235 212
Measure Type: Count of Participants
Unit of Measure: Participants
23
   9.8%
23
  10.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Individualized Approach, Household Approach
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments testing non-inferiority of individualized approach compared to household approach.
Statistical Test of Hypothesis P-Value 0.757
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Incidence of SSTI at 1 Month After Decolonization
Hide Description Cumulative Number of Participants with SSTI at any time during the 1 Month following Decolonization protocol
Time Frame 1 month after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
449 of 474 participants were analyzed. The remaining 25 participants were lost to follow up for this time frame.
Arm/Group Title Individualized Approach Household Approach
Hide Arm/Group Description:

The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.

All members of the household will perform the decolonization regimen.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.
Overall Number of Participants Analyzed 237 212
Measure Type: Count of Participants
Unit of Measure: Participants
8
   3.4%
8
   3.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Individualized Approach, Household Approach
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments testing non-inferiority of individualized approach compared to household approach.
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Incidence of SSTI at 6 Months After Decolonization
Hide Description Cumulative Number of Participants with SSTI at any time during the 6 Months following Decolonization protocol
Time Frame 6 months after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
434 of 474 participants were analyzed. The remaining 40 participants were lost to follow up for this time frame.
Arm/Group Title Individualized Approach Household Approach
Hide Arm/Group Description:

The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.

All members of the household will perform the decolonization regimen.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.
Overall Number of Participants Analyzed 225 209
Measure Type: Count of Participants
Unit of Measure: Participants
32
  14.2%
33
  15.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Individualized Approach, Household Approach
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments testing non-inferiority of individualized approach compared to household approach.
Statistical Test of Hypothesis P-Value 0.687
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With Incidence of SSTI at 9 Months After Decolonization
Hide Description Cumulative Number of Participants with SSTI at any time during the 9 Months following Decolonization protocol
Time Frame 9 months after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
433 of 474 participants were analyzed. The remaining 41 participants were lost to follow up for this time frame.
Arm/Group Title Individualized Approach Household Approach
Hide Arm/Group Description:

The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.

All members of the household will perform the decolonization regimen.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.
Overall Number of Participants Analyzed 226 207
Measure Type: Count of Participants
Unit of Measure: Participants
39
  17.3%
35
  16.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Individualized Approach, Household Approach
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments testing non-inferiority of individualized approach compared to household approach.
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants With Incidence of SSTI at 12 Months After Decolonization
Hide Description Cumulative Number of Participants with SSTI at any time during the 12 Months following Decolonization protocol
Time Frame 12 months after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
417 of 474 participants were analyzed. The remaining 57 participants were lost to follow up for this time frame.
Arm/Group Title Individualized Approach Household Approach
Hide Arm/Group Description:

The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.

All members of the household will perform the decolonization regimen.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.
Overall Number of Participants Analyzed 218 199
Measure Type: Count of Participants
Unit of Measure: Participants
48
  22.0%
41
  20.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Individualized Approach, Household Approach
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments testing non-inferiority of individualized approach compared to household approach.
Statistical Test of Hypothesis P-Value 0.811
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants Colonized With MRSA at 1 Month After Decolonization
Hide Description Number of Participants Colonized with MRSA at the 1 Month longitudinal study visit
Time Frame 1 month after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
438 of 474 participants were analyzed. The remaining 36 participants were lost to follow up for this time frame or were not available for swabs at the time of the home visit.
Arm/Group Title Individualized Approach Household Approach
Hide Arm/Group Description:

The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.

All members of the household will perform the decolonization regimen.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.
Overall Number of Participants Analyzed 230 208
Measure Type: Count of Participants
Unit of Measure: Participants
45
  19.6%
20
   9.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Individualized Approach, Household Approach
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments testing non-inferiority of individualized approach compared to household approach.
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants Colonized With MRSA at 3 Months After Decolonization
Hide Description Number of Participants Colonized with MRSA at the 3 Month longitudinal study visit
Time Frame 3 months after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
433 of 474 participants were analyzed. The remaining 41 participants were lost to follow up for this time frame or were not available for swabs at the time of the home visit.
Arm/Group Title Individualized Approach Household Approach
Hide Arm/Group Description:

The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.

All members of the household will perform the decolonization regimen.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.
Overall Number of Participants Analyzed 224 209
Measure Type: Count of Participants
Unit of Measure: Participants
51
  22.8%
26
  12.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Individualized Approach, Household Approach
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments testing non-inferiority of individualized approach compared to household approach.
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
8.Secondary Outcome
Title Number of Participants Colonized With MRSA at 6 Months After Decolonization
Hide Description Number of Participants Colonized with MRSA at the 6 Month longitudinal study visit
Time Frame 6 months after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
431 of 474 participants were analyzed. The remaining 43 participants were lost to follow up for this time frame or were not available for swabs at the time of the home visit.
Arm/Group Title Individualized Approach Household Approach
Hide Arm/Group Description:

The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.

All members of the household will perform the decolonization regimen.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.
Overall Number of Participants Analyzed 227 204
Measure Type: Count of Participants
Unit of Measure: Participants
39
  17.2%
21
  10.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Individualized Approach, Household Approach
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments testing non-inferiority of individualized approach compared to household approach.
Statistical Test of Hypothesis P-Value 0.050
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
9.Secondary Outcome
Title Number of Participants Colonized With MRSA at 9 Months After Decolonization
Hide Description Number of Participants Colonized with MRSA at the 9 Month longitudinal study visit
Time Frame 9 months after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
422 of 474 participants were analyzed. The remaining 52 participants were lost to follow up for this time frame or were not available for swabs at the time of the home visit.
Arm/Group Title Individualized Approach Household Approach
Hide Arm/Group Description:

The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.

All members of the household will perform the decolonization regimen.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.
Overall Number of Participants Analyzed 226 196
Measure Type: Count of Participants
Unit of Measure: Participants
40
  17.7%
17
   8.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Individualized Approach, Household Approach
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments testing non-inferiority of individualized approach compared to household approach.
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
10.Secondary Outcome
Title Number of Participants Colonized With MRSA at 12 Months After Decolonization
Hide Description Number of Participants Colonized with MRSA at the 12 Month longitudinal study visit
Time Frame 12 months after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
407 of 474 participants were analyzed. The remaining 67 participants were lost to follow up for this time frame or were not available for swabs at the time of the home visit.
Arm/Group Title Individualized Approach Household Approach
Hide Arm/Group Description:

The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.

All members of the household will perform the decolonization regimen.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.
Overall Number of Participants Analyzed 215 192
Measure Type: Count of Participants
Unit of Measure: Participants
47
  21.9%
22
  11.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Individualized Approach, Household Approach
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments testing non-inferiority of individualized approach compared to household approach.
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
11.Secondary Outcome
Title Number of Participants Who Report Development of Adverse Effects Occurring During Decolonization Period
Hide Description Number of participants who report development of Nasal burning, itching, stinging, or runny nose or Skin itching, dry skin, or rash during the decolonization period.
Time Frame 1 week after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
309 participants were assigned decolonization measures as part of the protocol. Of these 11 participants were lost to follow-up and never returned their adherence documents. 4 participants did not complete any part of the assigned decolonization measures. The remaining 294 participants are analyzed.
Arm/Group Title Individualized Approach Household Approach
Hide Arm/Group Description:

The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.

All members of the household will perform the decolonization regimen.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.
Overall Number of Participants Analyzed 84 210
Measure Type: Count of Participants
Unit of Measure: Participants
41
  48.8%
102
  48.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Individualized Approach, Household Approach
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments testing equivalence of individualized approach compared to household approach.
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
12.Secondary Outcome
Title Number of All Recovered S. Aureus Isolates With High-level Mupirocin Resistance
Hide Description Number of all recovered S. aureus isolates resistant to mupirocin at the study visit before decolonization protocol and the study visit immediately after decolonization protocol
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
All participants swabbed before decolonization. 438 participants swabbed at 1 mo. follow-up (after decolonization) - remaining 36 lost to follow-up or unavailable for swabs at home visit. This SECONDARY outcome is independent of study group, as the impact of the study on mupirocin resistance in overall study population is the outcome measure.
Arm/Group Title Before Decolonization After Decolonization
Hide Arm/Group Description:
All isolates recovered across study before decolonization protocol began (enrollment visit)
All isolates recovered across study directly after decolonization protocol (1 month visit)
Overall Number of Participants Analyzed 474 438
Overall Number of Units Analyzed
Type of Units Analyzed: Isolates Analyzed/Recovered
808 492
Count of Units
Unit of Measure: Isolates Analyzed/Recovered
31
   3.8%
20
   4.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Before Decolonization, After Decolonization
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments testing equivalence of before and after decolonization protocol.
Statistical Test of Hypothesis P-Value 0.84
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
13.Secondary Outcome
Title Number of Participants Incurring Economic Burden of Performing Protocol
Hide Description Number of participants incurring additional costs during their compliance with prescribed hygiene measures prescribed with the decolonization regimen: e.g., cost of containers of lotion or bars of soap discarded, cost of new pump or pour lotion or soap purchased, cost of new personal hygiene items or linens, cost of additional loads of laundry
Time Frame 1 month after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
435 of 474 participants returned their cost of protocol documentation. This SECONDARY outcome is independent of study group, as the economic impact of the study in the overall study population is the outcome measure.
Arm/Group Title Entire Study Population
Hide Arm/Group Description:
Additional costs of associated with protocol across all participants
Overall Number of Participants Analyzed 435
Measure Type: Count of Participants
Unit of Measure: Participants
75
  17.2%
14.Secondary Outcome
Title Number of Participants Reporting a Confirmed MRSA Infection Over the 12-month Longitudinal Study Period.
Hide Description Number of participants reporting the development of a MRSA infection over the year of longitudinal follow-up that has been culture- and physician-confirmed through verification by medical record and culture report.
Time Frame 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
416 of 474 participants were analyzed. The remaining 58 participants were lost to follow up for this time frame and outcome.
Arm/Group Title Individualized Approach Household Approach
Hide Arm/Group Description:

The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.

All members of the household will perform the decolonization regimen.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.
Overall Number of Participants Analyzed 218 198
Measure Type: Count of Participants
Unit of Measure: Participants
14
   6.4%
8
   4.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Individualized Approach, Household Approach
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments testing non-inferiority of individualized approach compared to household approach.
Statistical Test of Hypothesis P-Value 0.381
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
15.Secondary Outcome
Title Number of Participants Adhering to Decolonization Measures
Hide Description Number of participants Adhering to decolonization measures. Defined as reported completion of at least 4 of the 5 assigned days (8 or more mupirocin applications and 4 or more bleach baths)
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
309 participants were assigned decolonization measures as part of the protocol. Of these 11 participants were lost to follow-up and never returned their adherence documents. The remaining 298 participants are analyzed.
Arm/Group Title Individualized Approach Household Approach
Hide Arm/Group Description:

The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.

All members of the household will perform the decolonization regimen.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.
Overall Number of Participants Analyzed 86 212
Measure Type: Count of Participants
Unit of Measure: Participants
61
  70.9%
130
  61.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Individualized Approach, Household Approach
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments testing equivalence of individualized approach compared to household approach.
Statistical Test of Hypothesis P-Value 0.143
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Individualized Approach Household Approach
Hide Arm/Group Description

The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.

All members of the household will perform the decolonization regimen.

2% mupirocin ointment: Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.

Bleach Bath (dilute): Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.

Hygiene Protocol: Follow key hygiene tips:

  • Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
  • Use liquid(pour or pump) soaps instead of bar soaps.
  • Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
  • Do not share personal care items such as razors, brushes, or deodorant.
  • Wash all sheets and towels in hot water. Wash sheets every week.
  • Use towels and wash cloths only once before washing and do not share.
All-Cause Mortality
Individualized Approach Household Approach
Affected / at Risk (%) Affected / at Risk (%)
Total   0/248 (0.00%)   0/226 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Individualized Approach Household Approach
Affected / at Risk (%) Affected / at Risk (%)
Total   0/248 (0.00%)   0/226 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Individualized Approach Household Approach
Affected / at Risk (%) Affected / at Risk (%)
Total   41/248 (16.53%)   102/226 (45.13%) 
General disorders     
Itching (from mupirocin)   6/248 (2.42%)  19/226 (8.41%) 
Runny nose (from mupirocin)   11/248 (4.44%)  30/226 (13.27%) 
Itching (from bleach baths)   11/248 (4.44%)  31/226 (13.72%) 
Dry skin (from bleach baths)   24/248 (9.68%)  57/226 (25.22%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Stephanie Fritz, MD, MSCI
Organization: Washington University School of Medicine
Phone: 3144544115
Responsible Party: Stephanie A. Fritz, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01814371     History of Changes
Other Study ID Numbers: R01HS021736 ( U.S. AHRQ Grant/Contract )
First Submitted: March 15, 2013
First Posted: March 19, 2013
Results First Submitted: April 9, 2018
Results First Posted: October 26, 2018
Last Update Posted: February 21, 2019